This study employs a non-randomized, open-label design to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of DC50292A tablets in patients with MTAP-deficient advanced or metastatic solid tumors. The study consists of two parts: dose escalation and dose expansion.
Voluntarily signs the informed consent form, demonstrates understanding of the study, and is willing and able to comply with all trial procedures.
Age ≥18 years, regardless of gender.
Patients with histologically and/or cytologically confirmed solid tumors who are assessed by the investigator as having locally advanced, recurrent, or metastatic disease and have failed standard treatments at the current stage.
At least one measurable lesion as per RECIST v1.1 criteria, assessed via imaging (tumor lesions located in previously irradiated areas or those having undergone other local-regional therapies are generally not considered measurable unless clear progression is confirmed by the investigator).
Received chemotherapy, radiotherapy, biologics, endocrine therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, including: nitrosoureas or mitomycin C within 6 weeks prior; oral fluoropyrimidines or small-molecule targeted agents within 2 weeks or 5 half-lives (whichever is shorter); Chinese herbal medicines with antitumor indications within 2 weeks prior.
Received any non-marketed investigational drugs or therapies within 4 weeks prior to the first dose.
Undergone major organ surgery (excluding needle biopsy or surgery for pathologic fractures), significant trauma, or planned elective surgery during the trial within 4 weeks prior.
Used CYP3A4-sensitive substrates, strong inhibitors/inducers, CYP2C8-sensitive substrates, or P-gp inhibitors (see Appendix 3) within 14 days or 5 half-lives (whichever is shorter) prior.
Sequential
DC50292A
DrugDC50292A tablet
Number of Participants With Adverse Events
Incidence and severity of adverse events as assessed by CTCAE Version 5.0
PK profile of DC50292A
Peak Concentration (Cmax): The maximum plasma concentration of the drug.
PK profile of DC50292A
Area Under the Curve from Time Zero to the Last Measurable Concentration (AUC0-t): The area under the plasma concentration-time curve from time zero to the last measurable concentration.
PK profile of DC50292A
Area Under the Curve from Time Zero Extrapolated to Infinity (AUC0-∞): The area under the plasma concentration-time curve from time zero extrapolated to infinity.
PK profile of DC50292A
Time to Reach Peak Concentration (Tmax): The time at which the peak plasma concentration is reached.
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